Effect of Biofeedback-Based Inertial Sensors Gait Training on Walking Parameters in Children With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gait cycle time
研究概览
简要总结
The goal of this clinical trial is to learn about the effect of biofeedback-based inertial sensors gait training on walking parameters in children with hemiplegia. The main question it aims to answer is:
Does biofeedback-based inertial sensors gait training have an effect on walking parameters in children with hemiplegia.
- Participants in the study and control groups will receive 30 minutes designed physical therapy program, three times per week for three successive months.
- Children in the control group will receive traditional gait training for 30 minutes, three times per week for three successive months.
- Children in the study group will receive 30 minutes biofeedback-based inertial sensors gait training session three times per week for three successive months.
详细描述
- The current study is randomized controlled trial (RCT).
- Thirty children with spastic hemiplegic CP of both sexes (8to 12 years) will be selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University.
- Children will be randomly assigned into two groups; group A (control) and group B (study).
- Children in both groups will receive traditional physical therapy program for 30 minutes, three times per week for three successive months. In addition, children in group A will receive traditional gait training for 30 minutes while children in group B will receive gait training using Steadys system for 30 minutes.
- Instrumentation for patient selection include:
1- Modified Ashworth' Scale: Spasticity of children participating in this study will be ranged from 1 to 1+. 2- The Gross Motor Function Classification System (GMFCS): Children participating in this study will be level I or II on GMFCS.
- Instrumentation for Evaluation include:
- Steadys Software System
The Steadys system primary components and adjustment mechanisms include:
- The Neurosens inertial measurement units (IMU) sensors
- Treadmill
- BFB Monitor
- Record
- Patient folder
- Report For Treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Their age will range from 7 to 12 years.
- •The degree of their spasticity will range from 1 to 1+ according to Modified Ashworth' Scale (Bohannon et al., 1987) (Appendix IⅠ).
- •They will be on level Ⅰ or Ⅱ on GMFCS (Palisano et al., 2007) (Appendix IⅡ).
- •They will be able to walk without the use of an assistive device
- •Children can follow instructions and understand given orders.
排除标准
- •Severe visual or hearing impairment.
- •Fixed deformities or surgical interventions in the lower extremities.
- •Botulinum toxin injections in the last 6 months.
结局指标
主要结局
Gait cycle time
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in gait cycle time measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Step time
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in step time measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Cadence
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in cadence (steps/minute) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Stance phase
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in stance phase duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Single support
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in single support duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Double support
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in double support duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Swing phase
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in swing phase duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Stride length
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in stride length (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Gait speed
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in gait speed measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Foot clearance
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in foot clearance (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Swing width
时间窗: Baseline and immediately after completion of the 3-month intervention.
Change in swing width (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
次要结局
未报告次要终点
研究者
Naglaa Ezzat Abd Allah Mahmoud
Assistant Lecturer
Cairo University